SPINE Volume 39, Number 22S, pp S99-S105 ©2014, Lippincott Williams & Wilkins

ASSESSING VALUE OF SPECIFIC SPINE CONDITIONS

Cost-effectiveness of Surgery in the Management of Metastatic Epidural Spinal Cord Compression A Systematic Review Michael G. Fehlings, MD, PhD, FRCSC, FACS,* Anick Nater, MD,* and Haley Holmer, MPH†

Study Design. Systematic review. Objective. To perform an evidence-based synthesis of the literature to examine the cost-effectiveness of surgery in the management of metastatic epidural spinal cord compression (MESCC). Summary of Background Data. Between 2.5% and 10% of patients with cancer develop symptomatic MESCC, which leads to significant morbidity, and a reduction in quality and length of life. Although surgery is being increasingly used in the management of MESCC, it is unclear whether this modality is cost-effective, given the relatively limited lifespan of these patients. Methods. Numerous databases were searched to identify full economic studies based on key questions established a priori. Only economic studies that evaluated and synthesized the costs and consequences (i.e., cost-minimization, cost-benefit, costeffectiveness, or cost-utility) were considered for inclusion. Two independent reviewers examined the full text of the articles meeting inclusion criteria to obtain the final cohort of included studies. The Quality of Health Economic Studies instrument was scored by 2 independent reviewers. Results. The search strategy yielded 38 potentially relevant citations, 2 of which met the inclusion criteria. One was a costutility study and the other was a cost-effectiveness study, and both used clinical data from the same randomized controlled trial. Both studies found surgery plus radiotherapy to be not only more expensive but also more effective than radiotherapy alone in the management of patients with MESCC.

From the *Division of Neurosurgery and Spinal Program, University of Toronto, Toronto, Ontario, Canada; and †Spectrum Research, Tacoma, WA. Acknowledgment date: April 17, 2014. First revision date: June 23, 2014. Acceptance date: July 9, 2014. The manuscript submitted does not contain information about medical device(s)/drug(s). Supported by AO Spine North America, Inc. Analytic support for this work was provided by Spectrum Research Inc., with funding from the AO Spine North America. No relevant financial activities outside the submitted work. Address correspondence and reprint requests to Michael G. Fehlings, MD, PhD, FRCSC, FACS, Division of Neurosurgery and Spinal Program, University of Toronto, 399 Bathurst St, Ste 4W-449, Toronto, Ontario M5T 2S8, Canada; E-mail: [email protected] DOI: 10.1097/BRS.0000000000000525 Spine

Conclusion. There is evidence from 2 high-quality studies that surgery plus radiotherapy is costlier but clinically more effective than radiotherapy alone for the management of MESCC. Of note, cost-effectiveness data for the role of spinal stabilization in the management of oncological spinal instability are lacking. This is a key knowledge gap that represents an opportunity for future research. Key words: spinal metastasis, metastatic spinal cord compression, surgery, treatment, economic evaluation, cost, cost-effectiveness, cost-utility. Spine 2014;39:S99–S105

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he spine is a frequent site for metastases.1 Metastatic epidural spinal cord compression (MESCC) is a dreaded complication of cancer and has a major detrimental impact on quality of life. First described by Spiller2 in 1925, MESCC is characterized by an extradural mass associated with radiological evidence of compression of the spinal cord or cauda equina, causing clinical features such as: pain, motor, sensory, or sphincter dysfunction.3 Although up to 90% of patients with cancer have spinal metastases at autopsy,4 approximately 2.5% to 10% develop a symptomatic spinal metastasis.4–7 A recent populationbased study revealed that 3.4% of American patients with cancer develop MESCC per year.8 The median age at diagnosis is 40 to 65 years and there is an equal sex distribution. Although survival varies widely, the median survival is about 6 months.4,5,7 If left untreated, MESCC usually leads to severe pain and progressive neurological impairment.1,4–7 Consequently, MESCC is considered a condition that requires early diagnosis and expeditious treatment. Once cancer has become metastatic, it is rarely curable and treatments aim at maintaining function and quality of life, stabilizing the progression of disease, and minimizing complications. Therapeutic modalities in MESCC include various operative (open and minimally invasive procedures, kyphoplasty, and vertebroplasty) and nonoperative (corticosteroids, radiotherapy, and chemotherapy) alternatives. Although laminectomy followed by radiotherapy was once considered the mainstay of treatment,9 it fell into disfavor in the early 1980s when a number of retrospective studies10–12 and 1 small www.spinejournal.com

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ASSESSING VALUE OF SPECIFIC SPINE CONDITIONS randomized clinical trial (RCT)13 suggested that radiotherapy alone was as effective in relieving pain, and improving ability to walk and sphincter control. Also, Findlay14 reported that 51% of patients with MESCC treated with laminectomy showed evidence of vertebral collapse and more than 75% of patients experienced a major neurological deterioration postoperatively. With the advances in surgical decompressive and reconstructive techniques, surgery has regained a prominent role in the treatment of patients with MESCC. This shift in treatment approach has been propelled by a landmark RCT in which Patchell et al15 compared de novo circumferential decompressive and reconstructive surgery followed by radiotherapy to radiotherapy alone. The study demonstrated that surgery was associated with a higher rate of ability to walk (84% vs. 57%), promoted greater retention of ability to walk (median, 122 vs. 13 d), and enabled patients with paraplegia to recover the ability to walk more frequently (63% vs. 19%). Narcotics and steroids were also used less in the surgical group. In addition, patients who underwent surgery tended to survive longer (126 d vs. 100 d). Surgery did not increase the hospital stay and 30-day morbidity was worse in the radiotherapy only group. Moreover, recent meta-analyses have concluded that decompressive surgery followed by radiotherapy is associated with improved walking status16,17 and survival17 in comparison with radiotherapy alone in selected patients with MESCC. With an aging population as well as advances in diagnostic tools and treatment options, the incidence of MESCC is rising.18 MESCC is not only associated with significant physical and psychological consequences on patients and their family/ caregivers, but also comes with a heavy socioeconomic burden. Indeed, among patients with cancer in their last year of life, those with MESCC are hospitalized about twice longer.19 Furthermore, MESCC treated with surgery is the most expensive skeletal-related event in patients with cancer, costing nearly $83,000.20 With this background, we performed a systematic review of the literature to compare the cost-effectiveness of surgery with nonoperative management in MESCC. To accomplish this goal, we sought to answer the following key questions in adult patients with MESCC: 1. Is there evidence to suggest that surgery combined with pre- or postoperative radiotherapy is cost-effective compared with radiotherapy alone? 2. Is there evidence to suggest that surgery combined with chemotherapy and radiotherapy is cost-effective compared with radiotherapy and chemotherapy? 3. Is there evidence to suggest that surgical intervention for spinal instability, resulting from spinal metastasis itself or its treatment, is cost-effective compared with nonoperative treatment?

MATERIALS AND METHODS A detailed description of our methodology is provided in the Supplemental Digital Content, Appendix A available at http:// links.lww.com/BRS/A894. S100

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Surgery in the Management of MESCC • Fehlings et al

Electronic Literature Search A systematic search of PubMed, EMBASE, the Cochrane Collaboration database, University of York, Centre for Reviews and Dissemination (NHS-EED and HTA), and the Tufts CEA Registry was performed to identify studies examining the cost-effectiveness of surgery in the management of MESCC compared with nonoperative treatment. We searched the literature through January 18, 2014 and selected articles based on inclusion criteria outlined a priori in the PICO (Population, Intervention, Comparison, Outcome) table (Table 1). Our search included the use of both controlled vocabulary and key words to identify terms specific to MESCC, surgical decompression, radiotherapy, and economic evaluations. The formal search strategy is provided in the Supplemental Digital Content, Appendix B available at http://links.lww.com/BRS/A894. Studies published in any language in peer-reviewed journals that examined, compared, and synthesized the costs and consequences of alternative treatment options were considered for inclusion.

Study Selection and Data Abstraction One reviewer screened the electronic search results and excluded nonrelevant studies. Then, 2 reviewers screened the remaining titles and abstracts, retrieved the full texts of potentially relevant studies, and independently evaluated the studies against inclusion and exclusion criteria. Discrepancies were discussed and consensus was reached regarding final inclusion of studies. Data on type of economic evaluation, country, currency, model type, analytic perspective, clinical effectiveness data, costs included in the analyses, and results were abstracted into standardized abstraction tables.

Critical Appraisal The Quality of Health Economic Studies (QHES) instrument developed by Ofman et al21 was used to provide an initial basis for critical appraisal of the methodological quality of included economic studies21 and is described in detail in the Supplemental Digital Content available at http://links.lww.com/ BRS/A894. Factors important in critical appraisal of studies from an epidemiological perspective were also considered. Two reviewers independently applied the QHES instrument to included studies. Discrepancies in ratings were discussed, consensus was reached, and a final score was obtained.

RESULTS Our systematic search identified 38 articles. After excluding irrelevant studies based on title or abstract, 5 studies were retrieved for full text review, three22–24 of which did not meet inclusion criteria for our target population, study design, or intervention/comparison, respectively. Two articles25,26 met the inclusion criteria. An overview of the included studies, results, and limitations are provided in Tables 2 and 3, and summarized below. QHES scores are provided in the Supplemental Digital Content, Appendix C available at http://links. lww.com/BRS/A894; and detailed study characteristics and results are provided in the data abstraction tables in the Supplemental Digital Content, Appendix D available at http:// links.lww.com/BRS/A894. October 2014

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ASSESSING VALUE OF SPECIFIC SPINE CONDITIONS

Surgery in the Management of MESCC • Fehlings et al

TABLE 1. PICO Table Inclusion

Exclusion

Population

Adults with spinal metastasis or MESCC ± symptomatic (e.g., pain, neurological deficits, etc.) Spinal instability resulting from spinal metastasis itself or its treatment ± symptomatic

Intervention

KQ 1: Surgical intervention* combined with RT† KQ 2: Surgical intervention* combined with RT† and chemotherapy KQ 3: Surgical intervention (instrumentation ± fusion) to address spinal instability

Comparison

KQ 1: RT alone† KQ 2: RT† and chemotherapy KQ 3: nonoperative management

Outcome

ICER (or similar) Cost per unit of outcome

Study design

All language full economic studies

Spinal cord compression resulting from trauma, not in the context of spinal metastasis Pediatric (

Cost-effectiveness of surgery in the management of metastatic epidural spinal cord compression: a systematic review.

Systematic review...
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